Tuesday, May 3, 2016

Medical error

Medical error is the third leading cause of death in the United States, after heart disease and cancer, according to findings published today in BMJ.

As such, medical errors should be a top priority for research and resources, say authors Martin Makary, MD, MPH, professor of surgery, and research fellow Michael Daniel, from Johns Hopkins University School of Medicine in Baltimore, Maryland.

But accurate, transparent information about errors is not captured on death certificates, which are the documents the Centers for Disease Control and Prevention (CDC) uses for ranking causes of death and setting health priorities. Death certificates depend on International Classification of Diseases (ICD) codes for cause of death, so causes such as human and system errors are not recorded on them.

And it's not just the US. According to the World Health Organization, 117 countries code their mortality statistics using the ICD system as the primary health status indicator.

The authors call for better reporting to help capture the scale of the problem and create strategies for reducing it...

"Top-ranked causes of death as reported by the CDC inform our country's research funding and public health priorities," Dr Makary said in an university press release. "Right now, cancer and heart disease get a ton of attention, but since medical errors don't appear on the list, the problem doesn't get the funding and attention it deserves."

He adds: "Incidence rates for deaths directly attributable to medical care gone awry haven't been recognized in any standardized method for collecting national statistics. The medical coding system was designed to maximize billing for physician services, not to collect national health statistics, as it is currently being used."

The researchers examined four studies that analyzed medical death rate data from 2000 to 2008. Then, using hospital admission rates from 2013, they extrapolated that, based on 35,416,020 hospitalizations, 251,454 deaths stemmed from a medical error. 

That number of deaths translates to 9.5% of all deaths each year in the US — and puts medical error above the previous third-leading cause, respiratory disease.

In 2013, 611,105 people died of heart disease, 584,881 died of cancer, and 149,205 died of chronic respiratory disease, according to the CDC...

The authors suggest several changes, including making errors more visible so their effects can be understood. Often, discussions about prevention occur in limited and confidential forums, such as a department's morbidity and mortality conference.

Another is changing death certificates to include not just the cause of death, but an extra field asking whether a preventable complication stemming from the patient's care contributed to the death.

The authors also suggest that hospitals carry out a rapid and efficient independent investigation into deaths to determine whether error played a role. A root cause analysis approach would help while offering the protection of anonymity, they say.

Standardized data collection and reporting are also needed to build an accurate national picture of the problem.

Jim Rickert, MD, an orthopedist in Bedford, Indiana, and president of the Society for Patient Centered Orthopedics, told Medscape Medical News he was not surprised the errors came in at number 3 and that even those calculations don't tell the whole story.

"That doesn't even include doctors' offices and ambulatory care centers," he notes. "That's only inpatient hospitalization resulting in errors."

"I think most people underestimate the risk of error when they seek medical care," he said.

He agrees that adding a field to death certificates to indicate medical error is likely the way to get medical errors the attention they deserve.

"It's public pressure that brings about change. Hospitals have no incentive to publicize errors; neither do doctors or any other provider," he said.

However, such a major step as adding error information to death certificates is unlikely if not accompanied by tort reform, he said.

Still, this study helps emphasize the prevalence of errors, he said.

Human error is inevitable, the authors acknowledge, but "we can better measure the problem to design safer systems mitigating its frequency, visibility, and consequences."

They add that most errors aren't caused by bad doctors but by systemic failures and should 'not be addressed with punishment or legal action.


Martin A Makary, Michael Daniel.  Medical error—the third leading cause of death in the US.   BMJ 2016;353:i2139.


  1. Case history: role of medical error in patient death

    A young woman recovered well after a successful transplant operation. However, she was readmitted for non-specific complaints that were evaluated with extensive tests, some of which were unnecessary, including a pericardiocentesis. She was discharged but came back to the hospital days later with intra-abdominal hemorrhage and cardiopulmonary arrest. An autopsy revealed that the needle inserted during the pericardiocentesis grazed the liver causing a pseudoaneurysm that resulted in subsequent rupture and death. The death certificate listed the cause of death as cardiovascular.

    Martin A Makary, Michael Daniel. Medical error—the third leading cause of death in the US. BMJ 2016;353:i2139.

  2. Recent headlines telling us that medical errors are now the third leading cause of death deliver as much “news” as headlines telling us that Bill Clinton was the 42nd president of the United States. While the report in the BMJ — and the press release promoting it — sounded like researchers were on to something new, they were merely reminding us of old data.

    To get their estimate that medical errors cause 251,454 deaths a year among hospitalized patients in the United States, the authors essentially averaged error-related death rates from four prior studies and then extrapolated it to the number of hospitalized patients today. There is nothing bad about that, but there’s nothing tremendously innovative about it, either. If the researchers had really wanted to update the estimate for the modern age, they should have dug into patient records and made tough decisions about which deaths were truly due to errors — in other words, they should have done their own analysis.

    Here is one elephant in the room in this area of research: What is a medical error? The authors of the BMJ report define it as any action “that does not achieve its intended outcome” or any planned action that, for whatever reason, is not done “that may or may not cause harm to the patient.” This definition is uselessly broad. It is like dividing the world into the United States and all other countries, then engaging in diplomacy. Here’s a definition I think would be fair: A medical error is something a provider did or did not do that caused a bad outcome (death in this case) and — this is a big “and” — the action should have been done differently given what was known, or should have been known, at the time.(continued)

  3. (continued)
    By any decent definition, some errors are obvious, such as when a doctor or nurse gives a patient a wrong and deadly dose of a drug. But many “errors” exist in a gray zone. Say a doctor delays sending a patient to the intensive care unit and she later dies. Would she have died had she been transferred to the ICU 45 minutes sooner?

    When it comes to suspected errors, those who think they can always pinpoint which actions led to potentially preventable harm are either kidding themselves or are incredibly arrogant. One of the most difficult things about medicine is that much of the time we don’t know for sure if an outcome would have been different had we acted another way. Good doctors agonize about this.

    There’s another problem. The BMJ article, and the subsequent reporting about it, continue a trend where the public is wrongly told that all deaths are the same. They aren’t.

    When it comes to determining the impact of death, we intuitively understand that a 95-year-old dying of a medical error, while regrettable, is not as tragic as a 17-year-old dying from one. The 95-year-old had lived a full life, while the teenager missed out on so much. Most analyses treat each error-related death as the same. A better statistic to use would be years of life lost. It corrects for the fact that some deaths are more untimely than others.

    This doesn’t mean that any error is ignorable — it isn’t. But it means we ought to weigh medical errors fairly.

    The new estimate of 251,454 deaths matters because the sensational figure is imprecise and may be wrong by a large magnitude. The renewed attention on medical errors in hospitals might be good, prompting doctors to take it more seriously. But it could be harmful if it scares some people away from getting the care they need. It could also lead overzealous, out-of-touch hospital managers into constructing painful bureaucratic solutions to the problem of medical errors that ultimately don’t help. That happens. We are still living under one such regimen that doesn’t work — the universal use of gloves and gowns for all patient contact to prevent the spread of antibiotic-resistant bacteria in hospitals.

    Communicating scientific information isn’t easy. It’s natural to want to make journal articles and media reports sound interesting. But that shouldn’t sacrifice accuracy. Here’s how I would summarize the BMJ report: The authors made a number of reasonable proposals so we can better understand medical errors, which probably happen often but honestly aren’t something we have a good definition for and don’t do a good job of measuring or tracking.

    But you won’t get any great headlines out of that.

    Courtesy of Doximity

  4. The health news media were hopping recently with a big story about medical errors.

    Seemingly all the major outlets carried the story, with headlines so alarming that they'd have any conscious hospital patient demanding an immediate discharge.

    CBS: Medical errors now 3rd leading cause of death in U.S., study suggests
    Washington Post: Researchers: Medical errors now third leading cause of death in United States
    Nature World News: Medical Errors Now the Third Leading Cause of Mortality in U.S.

    These headlines all bore a striking resemblance to that of a Johns Hopkins news release about the study: Study Suggests Medical Errors Now Third Leading Cause of Death in the U.S.

    I call attention to the word "now" used in all of these headlines -- which suggests to the casual reader that the rate of medical errors is the United States is on the rise.
    But that's not what the BMJ paper found. And it's not how the paper described its conclusion in its own title: Medical error -- the third leading cause of death in the U.S.

    Using data from several older studies, the BMJ paper used a mathematical model to extrapolate a new and different total for medical error related deaths. And that total -- more than 250,000 -- is higher than estimates from previous research.

    But the paper did not attempt to assess trends in the rate of medical error-related deaths, nor did it collect any new data. So it's dubious to suggest -- without explanation -- that errors are "now" coming into 3rd place...

    But the problems run deeper than ambiguous headlines. As the blogger known as Skeptical Scalpel (a self-described former chairman of surgery) points out, the BMJ paper takes some pretty big leaps to come up with its new national total for error-related deaths. And the idea that all of these deaths are entirely preventable is also open to debate, he observes:
    "Makary's review extrapolated that figure [~250,000 deaths] from three papers published before 2009 which had a combined 35 supposedly preventable deaths. That's not a typo -- 35 deaths in all. One of the papers stated that all nine deaths in three tertiary care hospitals were preventable. In his BMJ paper, Makary says, 'some argue that all iatrogenic deaths are preventable.'

    "I disagree. I have analyzed other papers on this subject and pointed out that certain complications and deaths are not 100% preventable. For example, no study of deep venous thrombosis and pulmonary embolism shows total efficacy of any prevention strategy. And some patients will suffer myocardial infarctions and die even when they are properly treated."

    Thirty-five deaths extrapolated to 250,000?

    I'd like to have seen more reporters taking a closer look at those calculations.


  5. The study published in BMJ addressed the rate of fatal medical errors in the United States. The media has been very quick to pick up on this story and has already sensationalized the findings without carefully analyzing the data and how the study was conducted. While medical errors are a significant concern and result in countless cases of increased morbidity and mortality in the US today, I am not convinced as to the accuracy of the number of deaths that was determined in the study – over 200,000 deaths annually. Don’t get me wrong; I still believe this is a very important study. It brings more focused attention to the issue of medical errors, specifically how we can identify them and what systems are needed to prevent them from occurring in the first place...

    For starters, the authors used four separate studies to gather their data. Some of the studies that were used do not even make it clear what percentage of deaths due to errors were “preventable” and the Hopkins researchers simply assumed a rate of 100% in their analysis, which could have led to a gross overestimation of medical error related deaths. Moreover, some of the events classified as medical error related deaths were actually related to understaffing issues and lack of resources due to actual errors in the treatment of patients. Critics of the study have recalculated the death rate from these data and have determined the numbers to be nearly 30% lower than those presented in the results of the original paper. It is also important to note that in each study, non-medical personnel known as “coders” most often assigned the diagnostic codes that were used. Often times, many coders have less than six months of experience and do not fully understand the medical information that is documented in the chart. In many cases where a study is based on coder-generated data, it is “garbage in, garbage out.” However, no matter how you evaluate the study and its methodology, it is clear that medical errors are a significant problem that must be addressed...(continued)

  6. (continued)The issues with medical errors are quite complex. Certainly, when healthcare providers make poor clinical decisions, negative outcomes can occur, and handoffs of patients between physicians, nurses, and other hospital clinical workers can be haphazard and incomplete. Transitions of care are a major source of medical errors – when busy clinicians receive either incomplete or inaccurate “sign outs” important patient details can be lost. Labs may not be followed up, tests may not be ordered and care plans may not be followed. These types of errors can result in delays in treatment, wasted days in the hospital and incomplete follow up of results. Transitions between units can be even more problematic. When a patient is transferred between departments – such as between the ER and the ICU – medications can be forgotten and missed doses (or duplicated doses) of drugs are quite common. In addition, communication between caregivers can be rushed and important details can be left out....

    The advent of the electronic medical record (EMR) has given many healthcare professionals a false sense of security in that a patient’s story will be archived digitally for all to see. However, many EMRs are rather incomplete and the data required during documentation of a patient care event is inconsistent and often clinically irrelevant in the acute setting. System errors are the most common type of errors – these occur when the care systems and algorithms that are created within and between institutions are non-standardized and based on regional preferences. These inconsistencies can result in gaps in care. Safety measures and protocols are often inadequate to prevent error. What needs to be done going forward? It is clear there are far too many medical errors that occur in medicine in the US today. While I firmly believe that the current article far overestimates the total numbers of errors, the problem is still quite substantial. As physicians we must work together to create better ways to protect patients. We must do a better job communicating directly with one another about patients rather than rely too heavily on the EMR. Within hospital systems, we must put more checks and balances in place and make transitions between caregivers and units seamless. In addition, we must determine a more standardize way to define and measure medical errors – the creation of a national database may lead to important discoveries and allow us to provide safer, more efficient care for all of our patients in the future.

    - See more at: http://www.hcplive.com/medical-news/the-sensationalization-of-medical-errors-breaking-down-the-data-in-order-to-improve-patient-care?utm_source=Informz&utm_medium=HCPLive&utm_campaign=Trending%20News_5-24-16#sthash.DlGrRU7z.dpuf

  7. Medscape Medical News covered this analysis with the headline "Medical Error is Third Leading Cause of Death in US." Subsequently, more than 500 Medscape readers expressed everything from frank disbelief to admonishment for dissemination of the study's findings. Readers who found the study results credible and thought-provoking were decidedly in the minority. And although the comments often drifted into the realm of "everything that is wrong with healthcare today," the debate shines a light on a critical healthcare issue...

    The most frequent—though diametrically opposed—opinions offered by those who commented was that Makary and Daniel's definition of medical error was either too broad or not broad enough. An orthopedic surgeon wrote, "Just like the original To Err is Human, we are failing to properly distinguish between an error and a complication." This was echoed by an anesthesiologist, who wrote, "Hospital-acquired infection and pulmonary embolism were considered medical errors. While some can be attributed to care, many of these complications are unavoidable patient-related comorbidities." Likewise, a surgeon said, "There is a world of difference between error, bad results, and unintended consequences." A plastic surgeon agreed, writing that "what they considered errors are maloccurrences and complications with disappointing results that are unavoidable."

    Others pointed out that the term "medical error" is misleading, because it implies "physician error." They argue that a more appropriate term is "healthcare error,” because many different types of healthcare providers commit errors. Several readers believe that the category of medical error should be expanded to include "patient error." One physician wrote, "If medical error should be listed as a cause of death, then so too should patient error, or lifestyle error—namely, inhaled nicotine, overeating, sedentary living, and alcohol ingestion."...

    Clearly, surgery on the wrong part of the body, receiving the incorrect medication, or missing a diagnosis that is evident on a lab test or imaging study is a medical error. But what about the complications from a procedure? Consider this scenario: A patient with infection risk factors of poorly controlled diabetes and end-stage renal disease on hemodialysis underwent a life-saving procedure, developed an infection, became septic, and succumbed to the infection. Should this be considered a medical error? Unless there is an egregious fault in thinking or performance, or a trend for a certain practitioner or facility to have a significantly higher rate of complications, then I find it difficult (and irresponsible) to label these events "medical errors."


  8. Among the words we can publish that were used to describe Makary and Daniel's study findings were: "garbage," "tripe," "extrapolated hogwash," and "bogus." Still others described them as "outrageous," "absurd," "insulting," and "a joke."

    An internal medicine physician from Europe wrote, "The time has come when people won't die from their disease anymore—suddenly everyone will die from medical error? This is nonsense. From this article, you would think that doctors in the United States are dragging healthy people in off the streets and finishing them off."

    These numbers are total nonsense. It has been shown repeatedly (curiously left out of this article) that patients dying as a result of "error" are almost uniformly frail, weak patients whose life expectancies are short (ie, 6 months or less). These are not healthy individuals dropping dead from medical error. And the large majority would die from their conditions if it were not for major ongoing medical care. Moreover, any hospital-acquired infection or fall is considered an error. While I agree that reducing these events as much as possible is laudable, it defies common sense and practicality that these can be eliminated entirely. This is not a call to mediocrity, but an indictment of the methods used to calculate these results. Too often people want a grabby headline but don't present the whole, more complicated story. In the meantime, we lose patient trust. I urge a bit more responsibility.

    An oncologist criticized the study as "just another example of the endless ways to demean medical personnel. What a piece of hooey. I've seen plenty of people 'saved' from dying only to perpetuate their misery. Just walk through your local intensive care unit to witness it firsthand. The authors would have us believe that without medical errors, no deaths would occur—ever."


  9. Medical errors are hard to accurately quantify. They are hugely underreported and sometimes it's very hard to tell whether an error caused significant harm. I do want to point out the Dunning-Kruger effect that plagues medicine in certain areas where people are practicing at the edge of their scope and not appropriately asking for guidance. Be careful of the ego and try to be aware of what you don't know.

    A registered nurse was saddened reading some of the comments made about the study, saying, "Instead of asking what we can do about this problem, most are variations on exclamations of denial." Another healthcare provider concurred, saying, "Errors and complications are frequently faced by patients, even if doctors refuse to admit it. Why do so many women die from heart attacks after being sent home from the emergency department with a proton pump inhibitor or an antianxiety medication after being seen for chest pain?"...

    Preventable systematic lethal or egregious human errors do occur, but overall they are relatively small in number compared with random, unpreventable events. Oversight efforts to prevent these errors (eg, electronic health records) can have the opposite unintended consequence of increased random events, because quality provider-patient clinical 'face time' is reduced...

    Medscape was in for a share of the criticism, by virtue of reporting Makary and Daniel's findings as news. Some readers took Medscape to task for reporting on an inflammatory study that gives ammunition to the uneducated public and personal injury lawyers. A physician assistant pointed out that the study's title and the Medscape news headline were misleading since the study actually focused only on deaths that occurred in the hospital, not all deaths.

    An oncologist called the story "an irresponsible and provocative statement." That sentiment was echoed by a cardiologist who wrote, "Another irresponsible article is going to create more panic and mistrust of the medical profession. There are no data; mere suppositions and extrapolations of extrapolations. But once you launch a figure like 200,000 deaths, it will be impossible to cancel it from public opinion."


  10. Another physician commended the study for "directing attention to a part of the problem that really needs attention," but argued that it "fails to address the root causes of the problem of medical errors." A pediatrician who found the headline divisive also acknowledged that "the article opens a very important line of discussion and further study," adding, "I have no doubt that many deaths are due to clinician, nursing, and pharmacy error. Yet nowhere is it accounted for that the population as a whole is horribly sick from their own devices."

    One family physician did not doubt Makary and Daniel's findings and believes the source to be the EHR:

    "I hate to say it, but I see errors all the time. The amount of inaccurate information in the EHR is both astounding and frightening. Looking at hospital records the other day, I saw three different discharge doses of the same drug. I saw a patient with severe angioneurotic edema from an ACE inhibitor that was listed on the "continue these meds" discharge order. The EHR is overwhelming healthcare providers in the trenches with extraneous nonsense."

    A family physician encourages reflection rather than fault-finding, saying, "As healthcare becomes more complex, the risk for error increases greatly. Physicians often overestimate the benefit of a treatment or test and underestimate the potential harm. This study should remind us to be better informed and more thoughtful."

    And finally, this insight came from a pathologist: "To measure the present value of the healthcare system, we would need to know the death rate from no medical care."


  11. In a recent blog post, two physicians say a study recently published in BMJ that concluded medical error is the third leading cause of death in the United States is "shoddy" science.

    The paper was widely reported May 3 in print, broadcast, and online media, including by Medscape Medical News.

    Medical blogger Shyam Sabat, MD, an associate professor of neuroradiology at Penn State College of Medicine in Hershey, Pennsylvania, and Virginia Hall, MD, associate professor of obstetrics and gynecology at the college, say the article has unfairly condemned the US healthcare system and call for BMJ to retract the article and issue an apology to the US medical community. They have started a campaign on the online platform Change.org to support retraction. By July 11, the campaign had 176 supporters.

    They write in their post: "[T]he paper is a shoddy piece of scientific and statistical work which cannot stand the close scrutiny of peer physician researchers and professional statisticians."

    The journal, however, told Medscape Medical News a retraction is not warranted.

    Dr Sabat and Dr Hall write, "We reviewed the paper with expert statistician Dr. Vernon Chinchilli (Prof. and Chair Department of Public Health Sciences, Penn State College of Medicine), who found it shoddy science that the paper which calls itself a meta-analysis of four studies, is actually just a borrowed summary of a single study (by Healthgrades published in 2004). The other three studies just have 795, 838 and 2341 patients respectively versus 37 million in the Healthgrades study."(continued)

  12. (continued)The bloggers say the three other studies included in the analysis do not have the statistical power to be lumped in with the first study, and the conclusions actually belong to the Healthgrades 2004 study, which included only Medicare patients (who are aged 65 years and older).

    "Moreover, the authors borrowed the mortality rates from this Medicare population study and applied it to all U.S. inpatient admissions (all ages from 0-100+ years) without any correction of any form. It is common knowledge that the Medicare inpatient population is older, sicker and more vulnerable, and hence will have a higher morbidity and mortality for a given medical error than the general U.S. population," Dr Sabat and Dr Hall write.

    Navjoyt Ladher, MBBS, BMJ analysis and scholarly comment editor and a general practitioner, told Medscape Medical News, "We do not believe there are any grounds to retract the paper, and are not considering this course of action."

    "The BMJ's channel for debate and post-publication peer review of articles published in the journal is our rapid response section. We invite Dr Sabat and Dr Hall to make their points in a rapid response to the Analysis article, thus giving the authors of the article and other readers an opportunity to read and reply to their comments. We will continue to watch closely as the discussion develops."

    E. John Orav, PhD, associate professor of medicine in biostatistics at Harvard Medical School and Brigham & Women's Hospital in Boston, Massachusetts, agrees there is no need for a retraction.

    He told Medscape Medical News that part of the problem in the debate is the blog authors' repeated use of the term "meta-analysis," a term study authors Martin Makary, MD, from the Department of Surgery at Johns Hopkins University School of Medicine in Baltimore, Maryland, and Michael Daniel, a research fellow in the same department, did not use in the original paper.

    Dr Orav noted: "A meta-analysis is a rigorous, formal method for addressing a scientific question by combining results from previously published studies, rather than by collecting new primary data. The process involves a comprehensive process for identifying and rating the published studies, sometimes giving quality scores to the studies, and then choosing from a number of possible statistical methods for combining the results of the studies.

    "If the authors of the BMJ article had claimed their study to be a meta-analysis, they would indeed have done a poor job."

    Instead, he said, and the authors state, it is a less formal literature review, which, Dr Orav says, "consequently promises the reader less in terms of statistical rigor."…

    A true meta-analysis "would also have weighted the combined estimate to emphasize the largest study. And, if we ignore the Healthgrades study and focus on only the other three studies, we would rank medical errors as third, using the Office of the Inspector General, third using Classen et al, and fourth using Landrigan et al. I don't think that the conclusion of the study hinges on this criticism," Dr Orav said.

    As to the point that the conclusion borrowed the summary of a single study, he agrees the authors do not explicitly point out the BMJ paper final estimate reflects the Healthgrades result almost exclusively.

    "This point is important enough that it should have been emphasized in the article," he said.

    He also agrees with the blogger's criticism that "the authors borrowed the mortality rates from this Medicare population study and applied it to all U.S. inpatient admissions without any correction of any form."

    "This statement is true and the criticism is warranted," he said. "Since Medicare patients account for only one third of all deaths, extrapolating to the other two thirds of deaths is risky."


  13. From Dr. Sabat's blog:

    The paper, which likely purposefully has a tabloid type spicy headline, has expectedly already garnered widespread attention in the print, online and TV media as well as the blogosphere and social media. The paper is being cited in the same breath as the very famous Institute of Medicine (IOM) 1999 paper titled: "To Err is Human."

    But luckily for the U.S. medical/paramedical personnel and patients (and unfortunately for the authors and publishers), the paper is a shoddy piece of scientific and statistical work which cannot stand the close scrutiny of peer physician researchers and professional statisticians...

    How a reputed group such as the BMJ could not see through these simple but outrageous statistical blunders is anyone's guess. Did the overwhelming incentive to get a spice tabloid-type, eye-catching headlined paper, prevent the editorial process from taking common sense decisions?

    The result is that the U.S. medical community is being ridiculed by media and people not only from the U.S. but the whole world who cannot understand how U.S. medical system is so incompetent despite spending the maximum in the world and attracting the best talents from all over the world.

    We demand that the BMJ group immediately retract the paper and issue a widely circulated apology to counter the blame and shame the U.S. medical community has already received from its reckless act. This paper has also possibly done a lot to harm to the provider-patient relationship.